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Smiths Medical Pm, Inc.

USA · Waukesha

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class III 7

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 5 510(k), 0 PMA, 10 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: SMITHS MEDICAL PM, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K083557	BCI WW1030 PULSE OXIMETER	2009-05-01
US	K090205	BCI WW1021 PC APPLICATION	2009-04-28
US	K083787	BCI WW1000 PULSE OXIMETER, MODEL WW1000	2009-04-15
CA	12324	8200 CAPNOCHECK	Class III
CA	12790	CAPNOGRAPH/OXIMETER 9000 & CAPNOGRAPH 9001 MONITORS	Class III
CA	12791	9100 MULTIGAS MONITOR	Class III

Smiths Medical Pm, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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